MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751NAS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

Unit received with unresponsive buttons due to unlocked j2 / lcd connector and flattened esc and act dome switches (no creased).Unable to verify operational currents or perform rewind, basic occlusion test, occlusion test, prime/delivery test, excessive no delivery test, self test, unexpected restart error test, displacement test, dat test or verify meter error alarms or memory reset anomaly due to unresponsive keypad anomaly.

Event Description

The customer reported via phone call the insulin pump had a keypad anomaly and high blood glucose event.The customer¿s blood glucose was 400 mg/dl at the time of incident.Customer stated that the insulin pump buttons were unresponsive.No significant events leading to keypad anomaly were observed.Keypad anomaly troubleshooting was performed and confirmed that time is advancing.Customer had a high blood glucose of 400 mg/dl that requires medical assistance.Customer was treated at the er.Customer's blood glucose reading was 550 mg/dl at the time of call.The customer was wearing the insulin pump during the hospitalization.The customer was advised to change the infusion set, reservoir and insulin and to treat per healthcare professional's recommendation.The insulin pump is being replaced and is expected to return for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAS
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 7627958
• MDR Text Key: 111975023
• Report Number: 3004209178-2018-84036
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503717
• UDI-Public: (01)00643169503717
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A4751NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Weight: 170